Vaginal dilators have been used for many years in medicine for a wide variety of applications including oncology, radiotherapy, gynecology, obstetrics and sex therapy. Vaginismus is gynecological condition involving involuntary contraction of the muscles surrounding the entrance to the vagina, making penetration impossible and/or painful. Vaginal agenesis is a birth defect or congenital disorder where sufferers have a short vagina (neo-vagina) or no vagina at all.
Treatment of these conditions may involve surgery followed by a period of vaginal training using dilators. Even in cases where surgery is not needed, medical dilators are used. There is also much post-operative need for dilation treatment. For example, vaginal or anal prolapse surgery treats a condition where parts of the bladder, uterus, and/or rectum protrude from the vagina or anus. This type of surgery is commonly followed up with dilation treatment.
For all of these conditions, vaginal dilation is a significant part of the treatment procedure and is likely to remain important for the remainder of the patient's life. In use, these dilators are typically inserted into the vaginal cavity for sessions of varying length, such as from about 10 minutes to about 1 hour, from one to several times daily, which eventually allows for the gradual enlargement of this orifice.
There are some vaginal dilators on the market, however, none currently provide an effective treatment which encourages expansion of the vaginal wall and the ability to manipulate various features of the device without having to switch out parts and/or manipulate the device while it has already been inserted into the orifice desired for treatment. Currently, dilator kits may be found on the market, which consist of a series of dilators of increasing length and diameter used in order to gradually expand the vaginal orifice. This type of product is undesirable because it comes with multiple parts which must be manipulated by the user.
For example, US 2007/0043388 discloses a kit comprising a series of dilators which are color coded because the difference in diameter from one dilator to the next may be small and hence not readily determined by sight or feel. This makes usage by the patient difficult, confusing and time consuming. Additionally, the user must choose which size of dilator to use and may not necessarily encourage stepping up to a larger size diameter even though the patient has grown accustomed to the smaller size, thus hindering progress of treatment. Furthermore, when these dilators are inserted into the vagina, there is no expansion or retraction movement of the device which may encourage slow gradual expansion of the vaginal wall.
Balloon dilators are also sold in the market, however these types of dilators are associated with many drawbacks. For example, because of their inflatable nature, these products are not able to achieve a true uniformity of diameter along the length of the device. Any expansion or retraction provided by these types of devices is not easy to control by the user. Also, these types of dilators cannot be subjected to heat and therefore do not encourage optimized conditions for the patient who may desire or require a heated device for insertion into the orifice to be treated.
There is therefore a need for a dilator device which incorporates a variety of different sizes of diameters in a single device which can be uniformly expanded and contracted along the length of the device, according to the patient's preferences or physician's recommendations. Furthermore, there is a need for a single device which does not require several parts which must be switched out by the patient during treatment in order to facilitate adjustment of the device. There is also a need for a dilator device which encourages gradual expansion of the internal orifice tissues by creating a warm or heated environment when the device is in use.